# K191795: AOCup Lens Case with AODisc

- Pathway: 510(k) (Special)
- Applicant: Alcon Laboratories, Inc.
- Decided: Jul 31, 2019 after 28 days
- Product code: LPN (Accessories, Soft Lens Products)
- Device class: 2
- Regulation: 21 CFR 886.5928
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003345 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P820040: Septicon (TM) Disinfection Regimen for Use with, Ciba Vision Care. FDA lists this PMA only through its supplements; the earliest we hold is P820040/S001 (Dec 23, 1983). Summary page 5.
- K162597: Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc, Alcon Laboratories, Inc. (2016) Summary page 5.
- K173538: Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc, Alcon Laboratories, Inc. (2017) Summary page 5.
- K003345: Aosept Plus Cleaning and Disinfecting Solution, Ciba Vision Corporation (2001) Summary page 5.
- K013512: Aosept Clear Care Cleaning and Disinfecting Solution, Ciba Vision Corporation (2001) Summary page 5.
- K022687: Aosept Clear Care Cleaning and Disinfecting Solution, Ciba Vision Corporation (2002) Summary page 5.
- K023455: Aosept Clear Care Cleaning and Disinfecting Solution, Ciba Vision Corporation (2003) Summary page 5.
- K030522: Aosept Clear Care Cleaning and Disinfecting Solution, Ciba Vision Corporation (2003) Summary page 5.
- K031521: Aosept Clear Care Cleaning and Disinfecting Solution, Ciba Vision Corporation (2003) Summary page 5.
- K142284: Clear Care Plus Cleaning & Disinfectiong Solution with Hydraglyde, Alcon Laboratories, Inc. (2015) Summary page 5.

## Indications for use
For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered 3% hydrogen peroxide contact lens solution.

Source page: https://510kreport.com/device/K191795
Methodology: https://510kreport.com/methodology